CLINICAL EXPERIENCE AND USE OF SABRIL IN PATIENTS WITH PARTIAL SEIZURES

这项多中心、开放标签、灵活剂量的长期研究的目标是 是为了进一步评估与使用该药物相关的安全性和有效性 在有部分癫痫发作的癫痫患者中应用沙培林， 生活方式受到不良的癫痫控制和/或 目前上市的抗癫痫药物(AEDs)的不良事件。 Sabril(500毫克片剂)将以开放标签瓶装供应。这个 剂量将滴定到每天2至3克的维持量。这个 这项研究的最大允许剂量为每天6克，由 调查员取决于患者的反应。疗效将被测量 根据患者对塞布瑞尔在癫痫控制方面的反应， 发作频率和发作类型。此外，患者对 选定的生活质量问题将使用QOLIE-10进行测量 (癫痫患者的生活质量)量表、病人和医生 将对药物治疗的全球评估进行评估。安全参数 将通过收集不良事件和监测进行评估 实验室价值。

The goal of this multicenter, open-label, flexible-dose, long-term study is to further evaluate the safety and efficacy associated with the use of Sabril in epilepsy patients having partial seizures, and whose lifestyle has been adversely affected by poor seizure control and/or adverse events from currently marketed anti-epilepsy drugs (AEDs). Sabril (500 mg tablets) will be supplied in open-label bottles. The dosage will be titrated up to a maintenance dose of 2 to 3 g/day. The maximum allowable dose for the study is 6 g/day, as determined by the investigator dependent on patient response. Efficacy will be measured by the patient's response to Sabril with regard to seizure control, seizure frequency and seizure type. In addition, patient responses to selected quality-of-life questions will be measured with the QOLIE-10 (Quality of Life in Epilepsy) instrument, and patient and physician global assessment of drug therapy will be evaluated. Safety parameters will be assessed through collection of adverse events and monitoring laboratory values.